Reported Feb 5, 2014 · Terminated
MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079…
SS Wholesale Inc. dba Jobbers Wholesale
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SS Wholesale Inc. dba Jobbers Wholesale · 16101 Garfield Ave · Paramount, CA · 90723
Is this the product you have?
- MaXtremeZEN capsules, 1 capsule per blister pack
- Distributed byP&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2
- Lot codes and dates
Lot #: JBP-L-1270-70Exp 12/16
- Amount recalled
- 2,395 blister packs total for all products
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Stop using this product now
Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved
Using this product could cause serious injury, illness or death — stop using it now.
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